MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number 5530-G-209

Device Problems Material Discolored (1170); Material Distortion (2977); Scratched Material (3020); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/22/2018

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.The following device was also listed in this report: unknown tibial component; cat# unknown; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

As reported: "patient had pain, implant was removed and replaced with new tibial component & poly".

Event Description

As reported: "patient had pain, implant was removed and replaced with new tibial component & poly".

Manufacturer Narrative

An event regarding pain involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection was performed as part of mar.The mar report noted that "damage consistent with the explantation process was observed on the distal and anterior surface of the insert.Impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Burnishing, scratching and third body indentations were observed on the insert.These are common damage modes of uhmwpe (reference 1).Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid.The mar report concluded that " damage consistent with contact against the insert and explantation damage were observed on the baseplate.Burnishing, scratching and third body indentations were observed on the insert.These are common damage modes of uhmwpe.Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid.Damage consistent with the explantation process and contact against the baseplate were also observed on the insert." clinician review: not performed as no medical records and/ or x-rays were provided.Product history review: a review of the product history review indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the event was not confirmed.The exact cause of the event could not be determined because further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7277377
• MDR Text Key: 100302722
• Report Number: 0002249697-2018-00458
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 5530-G-209
• Device Lot Number: LDU208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 04/26/2018
• Supplement Dates FDA Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention